FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
118585–118608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1991
AESCULAP SURGICAL ACCESSORIES
K913262 · GEY
Aesculap, Inc.
General & Plastic Surgery · 160d
Cleared Dec 30, 1991
ELECTROSCOPE MONITOR, EM-1
K913625 · GEI
Electroscope, Inc.
General & Plastic Surgery · 137d
Cleared Dec 30, 1991
SIMPEX INC. ORAL AND RECTAL THERMOMETERS
K913793 · FLK
Simpex, Inc.
General Hospital · 129d
Cleared Dec 30, 1991
OSTEO CERCLAGE WIRE
K914374 · JDQ
Osteo AG
Orthopedic · 90d
Cleared Dec 30, 1991
TRANSCERVICAL INTRAUTERINE KIT
K914387 · HGS
Telos Medical Corp.
Obstetrics & Gynecology · 90d
Cleared Dec 30, 1991
KELLER CARDIAC MONITOR MEDIL KMS870
K914576 · DRT
Keller Medical Specialties Products,...
Cardiovascular · 76d
Cleared Dec 30, 1991
FRAMES (SPECTACLES) VARIOUS TYPES
K914614 · HQZ
Match Optical Co.
Ophthalmic · 74d
Cleared Dec 30, 1991
SYSMEX NE-1500, MODIFICATION
K914744 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 69d
Cleared Dec 30, 1991
FUN FLOSS
K914962 · JES
Fun Floss Co.
Dental · 55d
Cleared Dec 30, 1991
NPG III CASTING ALLOY
K915247 · EJH
Aalba Dent, Inc.
Dental · 45d
Cleared Dec 30, 1991
LPG CASTING ALLOY
K915248 · EJH
Aalba Dent, Inc.
Dental · 45d
Cleared Dec 30, 1991
PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES
K915461 · ESD
Phonak, Inc.
Ear, Nose, Throat · 26d
Cleared Dec 30, 1991
PS MEDICAL VENTRICULOSTOMY KIT
K915546 · HBG
Pudenz-Schulte Medical Research Corp.
Neurology · 19d
Cleared Dec 27, 1991
SERIES 1500 12-LEAD ANALYSIS OPTION
K903644 · LOS
Marquette Electronics, Inc.
Cardiovascular · 501d
Cleared Dec 27, 1991
OLYMPUS RETRACTABLE VALVULOTOME
K911702 · MGZ
Olympus Corp.
Cardiovascular · 255d
Cleared Dec 27, 1991
GENESIS UNICOMPARTMENTAL KNEE SYSTEM
K912735 · HSX
Smith & Nephew Richards, Inc.
Orthopedic · 190d
Cleared Dec 27, 1991
ANGIOLAZ ANGIOSCOPE CATHETER
K913129 · LYK
Angiolaz, Inc.
Cardiovascular · 164d
Cleared Dec 27, 1991
MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES
K913175 · EJJ
G-C Intl. Corp.
Dental · 163d
Cleared Dec 27, 1991
DIGITRAPPER MARK III
K913387 · FFT
Synectics-Dantec
Gastroenterology & Urology · 151d
Cleared Dec 27, 1991
APEX(TM) PROSTATIC BALLOON DILATION CATHETER
K913477 · KOE
Peripheral Systems Group
Gastroenterology & Urology · 144d
Cleared Dec 27, 1991
KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM
K913492 · JWH
Kirschner Medical Corp.
Orthopedic · 143d
Cleared Dec 27, 1991
XEMEX TEMPORARY PACING CATHETER A MODIFIED
K913521 · LDF
Zeon Medical Corp.
Cardiovascular · 143d
Cleared Dec 27, 1991
ADVANTAGE V.S. CT/MR RAD DIAGNOSTIC WORKSTATION
K913770 · LNH
General Electric Co.
Radiology · 127d
Cleared Dec 27, 1991
PHACO TIP
K914229 · HQC
Tri-Star Ophthalmic
Ophthalmic · 98d